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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ovesco Endoscopy AG — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

222 daysmedian FDA review time
327 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG2025-12-182100
K242586ArgoCap (200.52)Ovesco Endoscopy AG2025-05-222650
K241858BARS Set (100.60)Ovesco Endoscopy AG2024-08-26600
K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.0Ovesco Endoscopy AG2022-08-11900
K200684gastroduodenal FTRD SetOvesco Endoscopy AG2020-06-02780
K183309stentfix OTSC System SetOvesco Endoscopy AG2019-10-223270
DEN160014remOVE SystemOvesco Endoscopy AG2017-12-226200
K170867FTRD System SetOvesco Endoscopy AG2017-07-251240
K153550FTRD System SetOvesco Endoscopy AG2016-10-123060
K150067OTSC ProctologyOvesco Endoscopy AG2015-09-162460
K141790AQANIFEOvesco Endoscopy AG2015-03-062470
K141794ENDO-MARYLAND DISSECTOROvesco Endoscopy AG2014-11-191400
K140923TRACTION POLYPECTOMY SNAREOvesco Endoscopy AG2014-11-182220
K101428OTSC (OVER-THE SCOPE-CLIP) SYSTEM SETOvesco Endoscopy AG2010-12-011940

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda